Kornimate/medical-research-clean huggingface dataset:
human samples and data repository

Conditions: Uveitis; Scleritis

Summary: this protocol will enable irb (institutional review board) review of proposed research using human samples and data collected under the terminated nih studies 04-ei-0065 and 96-ei-0096. data and samples may include demographic and personal health information, psychological or psychiatric testing, blood, urine, csf or other body fluids or tissues and results of medical and physiological evaluation and medical imaging. data and sample analyses are limited to those approved under the original protocols unless additional specific institutional review board approval is obtained.

objective: this protocol will enable prospective irb review of research using human samples and data collected under other branch protocols. study population: participants that were followed in terminated branch protocols under which data or samples were collected. design: samples and data will be brought under this protocol, analyzed and stored for uses specified in the original protocols and as additionally approved by the irb. outcome: the outcome of this protocol will be the storage, tracking, and utilization of samples and data obtained under terminated protocols. purpose: the purpose of this protocol is to enable prospective irb review of research using human samples and data collected under other branch protocols. participants: participants who previously participated in nih protocols whose wishes regarding use of their samples or data for research other than that specified in the initial protocol is not known may be enrolled in this protocol. at this time, there are no additional analyses planned outside of the original protocols, apart from those listed below. participant consent or irb approval for a waiver of additional informed consent will be sought prior to initiation of additional analyses.

Eligibility criteria:
* data analysis study

Keywords: scleritis intermediate uveitis posterior uveitis intraocular inflammatory disease data analysis data collection sample analysis
olympus - 19-gauge needle

Conditions: Lung Cancer

Summary: the purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.


Eligibility criteria:
inclusion criteria: * subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>0.5 cm in short axis on ebus or any lymph node with uptake on fdg-pet scan that is higher than background pet activity. * participants must lack bleeding disorders exclusion criteria: * subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure * subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary) * subjects on anticoagulation (other than aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
mechanistic assessment of the properties of saxagliptin in subjects undergoing coronary artery bypass graft surgery

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Disease

Summary: individuals with type 2 diabetes mellitus (t2dm) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. in this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (cabg) surgery. the investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. this study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after cabg surgery will produce better clinical outcomes (for example, better heart health).

this study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with type 2 diabetes mellitus (t2dm) undergoing cabg surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (cv) outcomes. approximately 74 subjects will be randomized and complete the study.

Eligibility criteria:
inclusion criteria: * known diagnosis of type 2 diabetes mellitus (t2dm) with glycosylated hemoglobin (hba1c) between 6.5% and 10%, inclusive. * stable doses of oral antihyperglycemic agents for at least 2 months * stable dose of chronic insulin therapy for at least 2 months * hba1c documented within 3 months before study enrollment * planned first elective coronary artery bypass graft (cabg) surgery exclusion criteria: * elevated creatine kinase-myocardial bands (ck-mb) or troponin level above the 99th percentile at screening * receiving incretin therapy or having received incretin therapy within the previous 2 months * type 1 dm or a history of ketoacidosis * women who are pregnant or breastfeeding * known end-stage kidney disease * known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (dpp-4) inhibitor * clinically apparent liver disease * history of pancreatitis

Keywords: diabetes diabetes mellitus type 2 diabetes cardiovascular disease coronary artery bypass surgery
redexam - reducing painful eye examinations in preterm infants

Conditions: Retinopathy of Prematurity

Summary: more than 8000 babies born \>8 weeks early or weighing less than 1500g at birth in the united kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (rop). less than 1 in 10 need treating, but to identify these all of them require eye examinations 1-2 weekly from 5 weeks. these tests are uncomfortable, upsetting for families, and cost considerable time and money. there is now a new urine test that might help identify babies with the highest risk of developing significant rop. this cheap test appears to predict which babies need treatment and could avoid invasive eye examination in thousands of babies. the test has so far only been used in 136 babies. it accurately predicted rop, but 136 babies cannot change practice. we need to test more babies including in the uk. this study is designed to test \>300 uk babies to see how accurately urine levels of ntprobnp predict development of rop needing treatment. we will also pool our data with other researchers across europe testing the same test to identify the best 'cut'-off' value for this test. in the future babies with urine levels of this chemical lower than this cut-off level would not need invasive eye examinations. if this test works as we hope it will many babies will avoid repeated painful eye tests, and their families will be saved the stress of watching this being done, by replacing these with a simple easy cheap pain free urine test. there will be substantial savings in health care costs that could be used to improve other aspects of care. in resource poor settings without an expert ophthalmologist babies could be screened for rop that currently cannot be screened. we hope to demonstrate this to be a family-friendly, achievable intervention that positively impacts on the lives of babies and families experiencing neonatal intensive care.

see protocol

Eligibility criteria:
inclusion criteria: * preterm infants \<1500g or \<32 weeks gestation exclusion criteria: * separate ocular pathology
a multi-site trial of the impact of assistive technology with assistance users and their caregivers

Conditions: Mobility Disability; Older Adults; Community Dwelling

Summary: many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. assistive technology (at), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. although some research has reported beneficial outcomes of at use, few studies have used controlled experimental designs. furthermore, the results are often difficult to interpret because the at interventions are only vaguely described. another concern is that many individuals receive help from others, but scant attention has been paid to the impact of at on caregivers. this neglect produces an incomplete portrayal of the effect of at interventions. the proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic at intervention on individuals with mobility limitations and on their caregivers. the assistive technology provision, updating and training (atput)intervention involves a detailed in-home assessment of participants' current at; the negotiation and implementation of a personal at plan with the participants and their caregivers; and the provision of at devices, non-structural home modifications, and device training. objectives: 1. to determine the efficacy of the assistive technology provision, updating and training intervention for assistance users and for their caregivers. 2. to explore how the intervention is experienced by these individuals and to help explain the study findings. general hypotheses: the investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required. methodologies: this research will use a combination of quantitative and qualitative methods. the quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the atput or a customary care group.


Eligibility criteria:
inclusion criteria: * daily activity and/or mobility disability * referred to homecare * have an unpaid informal caregiver who is above the age of consent and willing to participate in the study * can communicate in english or french. exclusion criteria: * cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.

Keywords: assistive technology environmental modification caregiver client-centred
clinical study for the evaluation of p-3075 cream on acne treatment

Conditions: Acne

Summary: primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of p-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to cunliffe' classification. secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.

this is an open controlled clinical trial. the product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (t0), an intermediate visit after 2 weeks (t2) and a final visit after 4 week-treatment (t4). the subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe. each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks. a fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (t0). group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or aha until the end of the study.

Eligibility criteria:
inclusion criteria: * both genders; * age \> 16 years old; * acne of mild/moderate grade, not in therapy (group 1); * acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or aha (group 2); * accepting to follow the instructions received by the investigator; * available to return to the study centre at the protocol visits; * accepting to not change the normal life habits regarding: food, physical activity, face cleansing; * accepting not to receive any other drug/cosmetic treatment able to interfere with the study results; * accepting to sign the informed consent form (under 18 years the signature of both parents is required). exclusion criteria: * pregnancy (only for female subjects) - for subjects belonging to group 2, a control pregnancy test could be required at t2 and t4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies; * lactation (only for female subjects); * subjects whose insufficient adhesion to the study protocol is expected; * subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion; * concomitant participation in other studies or in the last 3 months.

Keywords: acne,comedones, oily skin
manipulation of arterial pressure in acute ischemic stroke

Conditions: Stroke, Acute

Summary: this is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to determine the effects of three levels of arterial pressure on death and neurological disability. after the admission in the vascular unit of the emergency department the patients are randomized to maintain during the first 24h the systolic arterial pressure in tree levels of pressure: 140 to 160 mmhg; 161 to 180 mmhg and 181 to 200 mmhg. the end point of the study is the modified rankin score and mortality in three month after the discharge.

to maintain the tree levels of systolic arterial pressure during de first 24h we will use one of the two strategies:1) infusion of 500 to 1000ml of saline solution and/or norepinephrine solution to increase de systolic pressure or 2) infusion of esmolol or nitroprussiate solution to decrease de pressure. every patient will have a transcranial doppler study in the first 24h to measure the mean velocity of cerebral arteries.

Eligibility criteria:
inclusion criteria: * patients 18 years or older, with the first acute ischemic stroke within the first 6 hours of the symptoms and not candidate to thrombolysis * we will also include patients with previous ischemic stroke with ranking score 0 or 1 exclusion criteria: * improuvment of the symptoms rapidly (in the first 15 min after admission) * seizures not related do the acute ischemic stroke * previous ischemic stroke in the last 6 weeks and with ranking score \> 1 * haemorrhagic stroke * anticoagulation * hypoglycemia * shock * acute heart failure

Keywords: stroke, acute systolic pressure of blood
an observational study to validate the cumulative life course impairment (clci) instrument (dermclci-p) in adult participants with moderate to severe chronic plaque psoriasis (pso)

Conditions: Psoriasis

Summary: the immagine study aims to validate the newly developed clci instrument (dermclci-p) in moderate to severe psoriasis (pso) patients, who will be started on risankizumb (rzb) treatment and will be enrolled into the validation study up to 28 weeks. the treatment decision for rzb must be made independent of this study enrollment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a dermatologist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment. * participants initiating rzb treatment for psoriasis as per local label. physician's decision for treatment with risankizumab must have been reached prior to and independently of recruitment in the study. * participants able to understand and communicate with the investigator and comply with the requirements of the study. * willingness and ability to comply with all study requirements. exclusion criteria: - current or recent (within the last 30 days) participation in an interventional clinical trial.

Keywords: plaque psoriasis pso psoriasis risankizumab rzb
hyperthermic intraperitoneal chemotherapy (hipec) in locally advanced gastric cancer

Conditions: Malignant Neoplasm of Stomach

Summary: the efficacy of hipec in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. the hypothesis of the trial is that radical gastrectomy combined with hipec is superior to only radical gastrectomy in terms of overall survival.

to determine the efficacy of hipec in the treatment of locally advanced gastric cancer, patients are randomized into hipec group and control group. in hipec group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with d2 lymphadenectomy and hipec with paclitaxel and 5-fu. patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with d2 lymphadenectomy. patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death. the trial is designed as a prospective, randomized, open and parallel group study.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of locally advanced gastric cancer. * no evidence of distant metastases or peritoneal metastases. * preoperative examination (ct/mri) demonstrated resectable gastric cancer with t3-t4 stage. * eligible for radical gastrectomy with d2 lymphadenectomy. * have not received cytotoxic chemotherapy or radiotherapy. * written informed consent is obtained prior to commencement of trial treatment. exclusion criteria: * existence of distant metastasis or peritoneal metastasis during surgery (m1). * any previous chemotherapy or radiotherapy * active systemic infections * inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * female patients who are pregnant or breast feeding
electrical control of bladder in spinal cord injury patients

Conditions: Spinal Cord Injury

Summary: the investigators will continue their work with implanted stimulators to improve bladder and bowel function. electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. by optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. this is part of a multi-center study with multiple support sources, including rehab r\&d, pva and a commercial stimulator company.


Eligibility criteria:
inclusion criteria: spinal cord injury with bowel \& bladder problems exclusion criteria:

Keywords: defecation electrical stimulation penile erection spinal cord injury urology
a psychological intervention for family caregivers of palliative care patients

Conditions: Palliative Care

Summary: this work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden. a parallel randomized controlled trial of two groups was performed. information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.


Eligibility criteria:
inclusion criteria: * to be the main family caregiver of a patient at the end of life, receiven palliative care. in the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family. * to have signed the informed consent. exclusion criteria: • to present cognitive impairment.

Keywords: intervention study family caregiver overburden anxiety depression
eus-fna in the pre-operative evaluation of patients with lung cancer

Conditions: Lung Cancer

Summary: this trial examines the role of eus-fna (oesophageal endoscopic ultrasound with fine needle aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer. patients will be randomized to either conventional surgical technique or eus-fna.


Eligibility criteria:
inclusion criteria: * patients with histological or cytological proof of non small cell lung cancer (nsclc) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or ct guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention * no distant metastases after routine clinical work up (pet is optional, not mandatory) * provision of a written informed consent * recent ct-scan of the thorax (\<28 days before randomization date) * age 18 years or older * clinically fit for surgery exclusion criteria: * proof of small cell lung cancer (sclc) with cwu (bronchoscopy or ct guided transthoracal punction) * stage iv nsclc * patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on ct and without mediastinal pet hot spots) : these do not require further mediastinal investigation * former therapy (chemotherapy or radiotherapy or surgery) for lung cancer * other concomitant malignancies * reasons for which the patient is unable to swallow the eus-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis) * uncorrected coagulopathy
detection of acute graft rejection in heart transplant patients by estimation of t2

Conditions: Acute Graft Rejection; Heart Transplantation

Summary: the investigators propose a simple and non-invasive method to monitor heart transplant patients with mri. its diagnostic and prognostic values have already been assessed in two monocentric studies. other monocentric studies based on related methods have confirmed the investigators findings. these studies are insufficient to allow a large diffusion of the technique. only a large multi-centric study will change medical practices. in addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with mri t2 quantification. furthermore, mri seems to detect rejections at earlier stage than biopsy. a confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. the ultimate aim of the draget project is to replace a strategy based solely on biopsy with one based on a first-line mri (with biopsy only when needed) for a more efficient and earlier detection of rejection. this would constitute a major advance in patients security and comfort as well as an economic improvement.


Eligibility criteria:
inclusion criteria: * heart transplant patient * able to realize 4 couples biopsy/mri within 12 months after the transplant * mandatory enrolment in a social security plan * patient having signed an informed consent. exclusion criteria: * contraindication to mri: pacemaker, ferromagnetic foreign body, etc * impossibility to undergo mri: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia * pregnancy * patients under a measure of legal protection

Keywords: mri, t2 quantification